Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419937

FEI Number

1419937

Entity Name

MEDELA LLC

City/State/Country

MCHENRY, IL, US

Establishment Address

1101 CORPORATE DR., MCHENRY, IL 60050, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDELA AG (Owner Number: 8030974)

Owner / Operator Contact Address

LAETTICHSTRASSE 4b, --, BAAR, CH-NOTA CH-6340, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intopo Oral Syringe Adapter Medela Low Dose Enteral Syringe Portable Manual Pump MEDELA NIPPLE SHIELDS Babyweigh II scale Baby Checker Scale Wound Dressing Set MEDELA INVIA MOTION MEDELA VARIO 8/18/CI MEDELA BASIC 30 MEDELA DOMINANT 35CI Tender Care Hydrogel Pad BRA COMPRESS GEL PAD Freestyle Mini Hands-free breast pump Feeding Tube Guardian Warmer Advanced Personal Double Breastpump; Pump In Style Advanced MEDELA CLARIO MEDELA SPECIAL NEEDS FEEDER MEDELA SOFTFEEDER MEDELA MINI SPECIAL NEEDS FEEDER MEDELA VARIO 8/18 Enteral Syringe with ENFit Connector Starter SNS Supplemental Nursing System (SNS) MEDELA SYMPHONY POWERED (MUTIPLE BRANDS) MEDELA BREASTPUMPS Pump In Style MEDELA BASIC 30 MEDELA VARIO 8/18/CI MEDELA DOMINANT 35CI Nipple Shield Contact Nipple Shield Swing Maxi Solo Symphony Reconditioned Symphony Rental Symphony Preemie+ Rental Symphony Plus Rental Symphony Preemie Consigment Pump Symphony Plus Breastpump (battery version) Symphony Breastpump Symphony Consignment Symphony Preemie+ Breastpump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-05-22
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2026-03-10
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-09-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-09-19
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2007-11-27
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2006-09-21
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2002-04-02
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2013-01-03
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2013-01-07
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2003-07-25
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2011-12-09
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	1991-02-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-04-13
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-05-23
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2014-05-23
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2018-11-06
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2007-11-27
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2006-09-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2007-11-27
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-07-20
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2012-12-12
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-02-14
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2006-09-21
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-07-06
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2003-07-25
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	1998-07-22
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2021-09-14
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-03-28
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2015-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDELA AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002807523	MEDELA AG	BAAR Zug, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1419937. Last updated year: 2026. Please use registration number 1419937 when referencing this establishment in official correspondence.